Post-extubation Assessment of Laryngeal Symptoms and Severity (PALSS) in the Intensive Care Unit: Protocol of a Prospective Cohort Study.

AIMS: The Post-extubation Assessment of Laryngeal Symptoms and Severity (PALSS) study systematically evaluates patient symptoms related to endotracheal intubation with mechanical ventilation, assesses laryngeal injury and voice function after extubation, and develops a screening tool to identify patients with clinically important, post-extubation laryngeal injury.

DESIGN

Single-center, prospective observational cohort study conducted in 6 intensive care units (ICU).

METHODS

Patients ≥18 years old who are orally intubated and mechanically ventilated in an ICU and meet eligibility criteria will undergo flexible laryngoscopy, with a sample size goal of 300 completed laryngoscopies. Primary outcome measures include signs and symptoms of laryngeal injury, including voice symptoms and alterations in swallowing, measured using the Laryngeal Hypersensitivity Questionnaire-Acute and Voice Symptom Scale questionnaires respectively. Data will be collected within 72 hours post-extubation and at 7-day follow-up or hospital discharge (whichever occurs first). Data will be analyzed using descriptive statistics, regression models, and predictive modeling using machine learning.

DISCUSSION: The findings of this study will describe the clinical signs and symptoms of laryngeal injury post-extubation.

CONCLUSION

The PALSS study will provide insights for future studies that explore laryngeal injuries using flexible laryngoscopy after endotracheal intubation.

IMPLICATIONS FOR PATIENT CARE: Identifying signs and symptoms of laryngeal injury after endotracheal intubation will facilitate the development of a screening tool that will assist in early identification of post-extubation laryngeal injury, and aid in decreasing short- and long-term complications of endotracheal intubation.

REPORTING METHOD: SPIRIT.

PATIENT OR PUBLIC CONTRIBUTION: Patients were study participants; and family members provided informed consent when the patient lacked decision-making capacity.